Safety of Soluble Beta-Glucan (SBG) in Treatment of Patients With Non-Hodgkin's Lymphoma

This study has been completed.

First Received: September 20, 2007 Last Updated: March 2, 2009 History of Changes

Sponsored by:	Biotec Pharmacon ASA
Information provided by:	Biotec Pharmacon ASA
ClinicalTrials.gov Identifier:	NCT00533728

Purpose

The purpose of this study is to assess the safety of soluble beta-glucan (SBG) in combination with antibody and chemotherapy treatment in patients with non-Hodgkin-s lymphoma.

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: Soluble beta-glucan (SBG)	Phase I

MedlinePlus related topics: Lymphoma

Drug Information available for: beta-Glucan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	A Phase I Study to Determine the Safety and Effect of Soluble Beta-Glucan (SBG) in Combination With Rituximab and COP/CHOP in Patients With Non'Hodgkin's Lymphoma

Further study details as provided by Biotec Pharmacon ASA:

Estimated Enrollment:	12
Study Start Date:	September 2007
Study Completion Date:	March 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

CD20 positive B-cell non-Hodgkin's lymphoma
Treatment with rituximab and CHOP or COP
Performance status 0 or 1 according to the WHO scale (Appendix)
Expected lifetime of more than 12 weeks
Age ≥ 18 years
The patient must be able and willing to comply with the study procedures, and signed and dated informed consent must be obtained

Exclusion Criteria:

Women who are pregnant or breast-feeding. For fertile women, a negative pregnancy test must be provided during the screening test. Women of childbearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation
Lymphoma involvement of central nervous system
Reduced bone marrow function defined by leukocyte counts < 3.0 x 109/l, neutrophil counts < 1.5 x 109/l, thrombocyte counts < 100 x 109/l or hemoglobin < 10 g/dl
Reduced liver function defined by bilirubin > 1.5 x upper limit of normal (ULN) or ASAT/ALAT ≥ 3 x ULN
Reduced renal function defined by serum creatinine ≥ 2 x ULN

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533728

Locations

Norway
Rikshospitalet, Kreftklinikken Radiumhospitalet
Oslo, Norway, 0310

Sponsors and Collaborators

Biotec Pharmacon ASA

Investigators

Principal Investigator:

Gustav Lehne, MD, PhD

Rikshospitalet HF

More Information

No publications provided

Study ID Numbers:	SBG-2-02
Study First Received:	September 20, 2007
Last Updated:	March 2, 2009
ClinicalTrials.gov Identifier:	NCT00533728 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency

Study placed in the following topic categories:

Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
Hodgkin's Disease

Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Hodgkin Disease
Lymphoma

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009